The US Senate Health, Education, Labor, and Pensions Committee approved the FDA Reauthorization Act, reauthorizing drug and device user fees and multiple additions device regulation reforms, on a 21-2 vote. The mark-up session also gave HELP members from both parties a chance to vent about provisions they'd want to see in a Senate version of an Affordable Care Act repeal bill.
The Senate HELP Committee agreed May 11, on a 14-2 vote, to move user-fee reauthorization legislation to the Senate floor.
The FDA Reauthorization Act (FDARA) that would enact the MDUFA IV user-fee agreement, and put into place an array of previously introduced, additional reforms related to device facility inspections, accessories, over-the-counter hearing aids and medical imaging
A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.
Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.
During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.
The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.
Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.
During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.
In Vivo spoke to the previous commissioner of the US FDA about recent ongoings at the agency, and where he believes policy should be directed for patient and industry benefit.
